EFFECT:Eccentric Fixation From Enhanced Clinical Training

NCT01499628 | Completed

• 2 other identifiers: RUBG1008Fight for Sight Ref: 1777/78
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Age-related macular degeneration (AMD) is the leading cause of severe visual impairment in the UK, Europe and N America. Low vision patients with AMD have great difficulty reading, which leads to a loss of independence and reduced quality of life. Magnifiers alone do not compensate for loss of central vision in AMD. It has been proposed that special low vision training can improve reading ability in patients with AMD. Training programmes are widely available in the US and Scandinavia, but not in the UK, partly because there is a lack of evidence from Randomised Control Trials (RCT) showing that they are effective. The investigators are conducting a clinical trial comparing the conventional hospital-based low vision service to enhanced rehabilitation programmes that include Eccentric Viewing training. Eccentric viewing training involves teaching patients who have lost their central vision to use a new area of retina for visual tasks. Patients are either taught to improve the use of the part of the retina they naturally start using after their central vision is lost, their so-called preferred retinal locus (PRL), or, alternatively, they are taught to use a different retinal area that is thought to be better suited for everyday visual tasks, the so-called trained retinal locus (TRL). The investigators plan to compare the two types of eccentric viewing training to conventional hospital-based low vision care.

Conditions

Age Related Macular Degeneration (ARMD)

Outcome Measures

Primary Outcomes (1)

• Score on the Massof Activity Inventory - 6 month follow up

  Change from Baseline in Massof Activity Inventory at 6 month follow up

Secondary Outcomes (19)

• Reading Speed (ReST) - Final Assessment

  Change from Baseline in Reading Speed (ReST) at Final Assessment

• Quality of Life (MacDQoL) - Final Assessment

  Change from Baseline in Quality of Life (MacDQoL) at Final Assessment

• Quality of Life (MacDQoL) - 6 month follow up

  Change from Baseline in Quality of Life (MacDQoL) at 6 month follow up

• Quality of Life (MacDQoL) - 12 month follow up

  Change from Baseline in Quality of Life (MacDQol) at 12 month follow up

• Self-reported health status (EQ-5D) - Final Assessment

  Change from Baseline in EQ-5D score at Final Assessment

Study Arms (4)

Group 1-Control

NO INTERVENTION

No extra training will be given.

Group 2-Control plus supervised reading

ACTIVE COMPARATOR

The same amount of contact time as Groups 3 and 4 - three 45 minute sessions completed over three weeks.

Behavioral: Supervised Reading

Group 3-EVT at the PRL

EXPERIMENTAL

Eccentric viewing training at the Preferred Retinal Locus (PRL), using reading/target cards. Three 45 minute sessions completed over three weeks.

Behavioral: EVT at the PRL

Group 4-EVT at the TRL

EXPERIMENTAL

Eccentric viewing training at the Trained Retinal Locus (TRL), using reading/target cards and microperimeter. Three 45 minute sessions completed over three weeks.

Behavioral: EVT at the TRL

Interventions

Supervised Reading BEHAVIORAL

Participant attends once a week for three weeks for a 45 minute appointment of supervised reading using appropriate spectacles and/or glasses

Group 2-Control plus supervised reading

EVT at the PRL BEHAVIORAL

Eccentric viewing training at the Preferred Retinal Locus (PRL), using reading/target cards. Three 45 minute sessions completed over three weeks.

Group 3-EVT at the PRL

EVT at the TRL BEHAVIORAL

Participant attends once a week for three weeks for a 45 minute appointment of TRL training using the MAIA microperimeter and then further reading using magnifiers and/or spectacles.

Group 4-EVT at the TRL

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of age-related macular degeneration
• Visual acuity 6/12 to 3/60 inclusive in the better eye
• Dense central scotoma confirmed by microperimetry

You may not qualify if:

• Patients who are not fluent in English or are cognitively impaired
• Patients with serious hearing impairment
• Patients who are hospital inpatients, who are living in nursing homes or are otherwise non-independent
• Ocular co-morbidity (other than mild cataract) in the better eye
• Recent low vision assessment or eccentric viewing training

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead
• British Eye Research Foundation, operating as Fight for Sight: collaborator

Study Sites (1)

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Gary S Rubin, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 26, 2011
• Study Start: April 27, 2011
• Primary Completion: November 26, 2015
• Study Completion: December 31, 2015
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

GB (1)